CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Baxter Clearlink System Solution Set with Duo-Vent Spike recalled
Baxter Healthcare is recalling Baxter Clearlink System Solution Set with Duo-Vent Spike, distributed nationwide in the US. The recall was initiated on 20 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1010-2025
- FDA event ID
- 95929
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 22 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 22 Jan 2025 | Classified by FDA | +33 days |
| 29 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Product as listed by the FDA
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Where it was distributed
US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.
Nationwide CaliforniaFloridaMassachusettsMinnesotaMissouriSouth CarolinaTexasVirginia
Questions about this recall
Why was it recalled?
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Which lots are affected?
UDI/DI 00085412676647, Lot Numbers: DR24C15109 (exp. 3/16/2026)
Where was it sold?
US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95929This product is part of a recall event; the main page for the event is Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled | Baxter Healthcare | Other | Nationwide | |
| CLASS II | Baxter Solution Set with Duo-Vent Spike recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
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